We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Drug Use Investigation for AVOLVE(BPH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01376284
First Posted: June 20, 2011
Last Update Posted: July 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
The study is designed to investigate the safety and efficacy of dutasteride capsules 0.5 mg collected from the required number of Japanese subjects with benign prostatic hyperplasia (BPH) in order to identify concerns or problems, if any, about the efficacy and safety of its use at post-marketing clinical settings.

Condition Intervention
Prostatic Hyperplasia Drug: Dutasteride

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Drug Use Investigation for AVOLVE(BPH)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules [ Time Frame: 1 year ]

Enrollment: 1000
Study Start Date: December 2010
Study Completion Date: June 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed dutasteride capsules
Subjects with BPH prescribed dutasteride capsules during study period
Drug: Dutasteride
Collection of safety data

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Japanese male adult subjects with benign prostatic hyperplasia (BPH) who start the treatment with dutasteride capsules
Criteria

Inclusion Criteria:

  • Must be male subjects
  • Use dutasteride capsules for the first time

Exclusion Criteria:

  • Subjects who is hypersensitivity to dutasteride or 5α reductase inhibitor
  • Subjects with severe hepatic function disorder
  • Dutasteride capsules shall not be used to female or child
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376284


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01376284     History of Changes
Other Study ID Numbers: 114125
First Submitted: June 9, 2011
First Posted: June 20, 2011
Last Update Posted: July 28, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Dutasteride
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs